This papers propose a pragmatic, simple and regulatory-acceptable solution to the supply shortage challenges it currently faces. It explores the diversity of registration practices for innovative and complex materials and illustrates this through a survey of the current state. The paper then offers a simplified harmonized approach for registration of materials, through a mature definition of product quality approach. This third case study in the series looking at increasing flexibility by a change in radiation for sterilization. However, the same mature approach to the definition of product quality that was used in the previous two papers is also used here. By reviewing the attributes of a material that are critical to product quality and assessing the potential risks linked to the change of sterilization method, the team was able to propose a consensual industry view on the change from gamma to x-ray sterilization for this family of products.
Viewing related articles
This guidance document and the accompanying XI risk evaluation tool define the BioPhorum approach to risk evaluation of X-ray irradiation for sterilization of single-use systems (SUS) and is a flexible resource for incorporation of supporting tools into end-user quality system documents. End-users are responsible for critically reviewing this content prior to application and selecting the aspects that are most aligned with internal procedures, as well as making refinements as needed to meet local requirements.
The BioPhorum Alternative to Gamma Sterilization workstream is focused, in partnership with the Bio-Process Systems Alliance, on raising awareness of the need for sterilization alternatives for single-use systems. As part of this work the team discovered a need to understand some of the first principles. This paper is to provide a lay person’s introduction to the need for change, the basic physics involved and a high-level comparison between x-ray and gamma